The United States Food and Drug Administration (USFDA) issued Form 483 to Aurobindo Pharma over observation on it's two units of Hyderabad.
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The United States Food and Drug Administration (USFDA) issued Form 483 to Aurobindo Pharma over observation on it's two units of Hyderabad.
A just-released study by UT Health San Antonio and collaborating institutions shows age-related decreases in blood flow to the brain and memory loss can be modified with the drug rapamycin.
Scientists funded by the National Institutes of Health have developed an investigational vaccine that protected cynomolgus macaques against four types of hemorrhagic fever viruses endemic to overlapping regions in Africa. The University of Texas Medical Branch in Galveston and Profectus BioSciences of New York are developing and testing the candidate quadrivalent VesiculoVax vaccine, with support from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and Redeemer’s University in Nigeria.
Shanghai Green Valley Pharmaceuticals (Green Valley) today announced that China's National Medical Products Administration (NMPA) has approved Oligomannate (GV-971) as new drug for the treatment of "mild to moderate Alzheimer's disease (AD) and improving cognitive function."
U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. The Sentosa SQ HIV Genotyping Assay is the first HIV drug resistance assay that uses NGS technology that the FDA has authorized for marketing in the U.S.
Investigators at the National Institutes of Health have found that sesame allergy is common among children with other food allergies, occurring in an estimated 17% of this population. In addition, the scientists have found that sesame antibody testing — whose utility has been controversial — accurately predicts whether a child with food allergy is allergic to sesame. The research was published on Oct. 28 in the journal Pediatric Allergy and Immunology.
Defying the odds, an individual at high risk for early-onset Alzheimer’s disease remained dementia-free for many years beyond what was anticipated<. A study funded in part by the National Institute on Aging (NIA), part of the National Institutes of Health, led researchers to suggest that a gene variant may be the key, perhaps providing a new direction toward developing a treatment.
Public health and safety is the highest priority at the U.S. Food and Drug Administration. We maintain a robust practice of postmarket surveillance and risk evaluation programs to identify new adverse events that did not appear during the product development process, or to learn more about known adverse events. Evaluations occur on more than two million adverse event reports submitted every year to the FDA Adverse Event Reporting System (FAERS) through the MedWatch Program and to the Vaccine Adverse Event Reporting System (VAERS) by patients, family members, and health care providers, as well as adverse event reports submitted by regulated industry. Staff in our Office of Surveillance and Epidemiology and CBER’s Office of Biostatistics and Epidemiology use this information to identify safety concerns and recommend actions to improve product safety and protect the public.
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A new analysis suggests that teens prefer mint and mango as their vaping flavors of choice for e-cigarettes. Previous research showed that teens were attracted to nicotine vaping by the candy and fruit-flavored products offered by manufacturers. Products and trends are quickly evolving, and estimates of the specific e-cigarette flavors teens use are lacking; therefore, scientists wanted to find out which flavors are now preferred by teens. The report, published in JAMA, was supported by the National Institute on Drug Abuse (NIDA), the National Cancer Institute (NCI), and the U.S. Food and Drug Administration Center for Tobacco Products. NIDA and NCI are parts of the National Institutes of Health.
The Union Cabinet chaired by the Prime Minister Shri Narendra Modi has approved the Memorandum of Understanding (MoU) between India and Brazil in the field of Health and Medicine. The MoU is expected to be signed in November, 2019.